An automated chromogenic test called the INNOVANCE Anti-Xa assay is used to quantify the levels of rivaroxaban1, apixaban, and edoxaban1 in citrated human plasma, as well as the activity of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH).
The INNOVANCE Anti-Xa assay combines a ready-to-use liquid reagent for heparin and DOAC testing, providing 24-hour access to quick, precise anticoagulant testing. Unlike other commercially available solutions, this assay does not require any manual preparation or waiting time. The INNOVANCE Anti-Xa assay may now also detect edoxaban.
Benefits
Anticoagulant testing, simplified
- Liquid reagents do not require manual preparation or reconstitution, allowing employees to focus on higher-value activities.
- The combined testing solution decreases the lab's handling, material, and ordering complexity
- A single calibration curve for UFH and LMWH reduces the possibility of evaluating the incorrect curve and simplifies the interpretation of results.
Available without the wait
- Timely treatment for patients is supported by round-the-clock access to quick, targeted anticoagulant testing
- An assay with a robust design is less susceptible to interferences
Improved diagnostic accuracy in heparin and DOAC testing
- The DOACs apixaban, edoxaban1, and rivaroxaban1 have drug-specific standards sets that make it possible to quantify drug concentrations in ng/mL with accuracy
- UF and LMW heparin have a wide and reliable assay range of 0.10 to 1.50 IU/mL, which can be increased to 2.25 IU/mL by sample dilution
- High lot-to-lot consistency, which contributes to long-term, reliable patient outcomes
Technical details
The INNOVANCE Anti-Xa assay provides strong performance in every parameter. Its portable and user-friendly design promotes better laboratory results. It utilizes the same proven components and expands upon the INNOVANCE Heparin assay’s proven performance, but it also has DOAC testing capabilities.
Measuring ranges
Technical specifications. Source: Siemens Healthineers
| . |
. |
| 0.10–1.50 IU/mL |
Consistent measuring range for UFH and LMWH, extendable up to 2.25 IU/mL by sample dilution |
20–350
ng/mL |
Measuring range for rivaroxaban1, apixaban, and edoxaban1, extendable up to 700 ng/mL by sample dilution |
Within device/Lab information
Technical specifications. Source: Siemens Healthineers
| . |
. |
| 0.010 IU/mL |
Within-device/lab SD of INNOVANCE Heparin LMW Control 1 |
| 0.014 IU/mL |
Within-device/lab SD of INNOVANCE Heparin UF Control 1 |
| 2.48% |
Within-device/lab CV of INNOVANCE Apixaban Control 1 |
| 2.13% |
Within-device/lab CV of INNOVANCE Rivaroxaban Control 11 |
2.0
ng/mL |
Within-device/lab SD for INNOVANCE Edoxaban Control 11
Within-device/lab CV (%) and within-device/lab SD indicated for CS-2500 System. Assay performance can vary from country to country as well as corresponding to the system application of the respective assay. The values listed above are provided as examples only. |
Additional information
Technical specifications. Source: Siemens Healthineers
| . |
. |
| 8 weeks |
Stability once opened at 2–8 °C |
Evidence
Learn more about the individual INNOVANCE Anti-Xa assay components
Image Credit: Siemens Healthineers
The INNOVANCE Anti-Xa assay simplifies handling, lowers order complexity, and provides laboratories with an affordable testing result by integrating heparin and DOAC testing into a single straightforward and user-friendly assay.
1. INNOVANCE Edoxaban Standards
Image Credit: Siemens Healthineers
INNOVANCE Edoxaban Standards1 are used to calibrate the INNOVANCE Anti-Xa assay. This allows for the quantitative determination of edoxaban concentration in citrated human plasma. The set includes two standards: Standard 0 (without edoxaban) and Standard 1 (containing approximately 420 ng/mL edoxaban).
SMN: 10873783
Package size: 2 × 2 × for 1 mL
2. INNOVANCE Edoxaban Controls
Image Credit: Siemens Healthineers
INNOVANCE Edoxaban Controls1 are designed for quality control of the INNOVANCE Anti-Xa assay. These controls are used to ensure the accurate quantitative determination of edoxaban in citrated human plasma. The set includes two levels: Control 1 with approximately 45 ng/mL edoxaban, and Control 2 with approximately 260 ng/mL edoxaban.
SMN: 10873784
Package size: 2 × 5 × for 1 mL
3. INNOVANCE Rivaroxaban Standards
Image Credit: Siemens Healthineers
INNOVANCE Rivaroxaban Standards1 are used to calibrate the INNOVANCE Anti-Xa assay. This enables the quantitative determination of rivaroxaban concentration in citrated human plasma. The set includes two standards: Standard 0 (without rivaroxaban) and Standard 1 (containing approximately 420 ng/mL rivaroxaban).
SMN/Catalog no.: 10873677/OPPT03
Package size: 2 × 2 × for 1 mL
4. INNOVANCE Rivaroxaban Controls
Image Credit: Siemens Healthineers
INNOVANCE Rivaroxaban Controls1 are designed to quality-control the INNOVANCE Anti—Xa assay. They are used for the quantitative determination of rivaroxaban in citrated human plasma. The set includes two levels of rivaroxaban controls: Control 1 (approximately 70 ng/mL) and Control 2 (approximately 260 ng/mL).
SMN/Catalog no.: 10873676/OPPS03
Package size: 2 × 5 × for 1 mL
5. INNOVANCE Heparin UF Control 2
Image Credit: Siemens Healthineers
INNOVANCE Heparin UF Control 2 is used for quality control with the INNOVANCE Heparin and INNOVANCE Anti-Xa assays. This control helps ensure accurate quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma, with a heparin concentration of approximately 0.7 IU/mL.
SMN/Catalog no.: 10873451/OPOD03
Package size: 5 × for 1 mL
6. INNOVANCE Heparin UF Control 1
Image Credit: Siemens Healthineers
INNOVANCE Heparin UF Control 1 is used for quality control with the INNOVANCE Heparin and INNOVANCE Anti-Xa assays. This control helps ensure the accurate quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma, with a heparin concentration of approximately 0.3 IU/mL.
SMN/Catalog no.: 10873452/OPOC03
Package size: 5 × for 1 mL
7. INNOVANCE Apixaban Standards
Image Credit: Siemens Healthineers
INNOVANCE Apixaban Standards are used to calibrate the INNOVANCE Anti-Xa assay for the quantitative determination of apixaban concentration in citrated human plasma. The set includes two standards: Standard 0 (without apixaban) and Standard 1 (containing approximately 420 ng/mL apixaban).
SMN/Catalog no.: 10873673/OPPW03
Package size: 2 × 2 × for 1 mL
8. INNOVANCE Apixaban Controls
Image Credit: Siemens Healthineers
INNOVANCE Apixaban Controls are designed to quality-control the INNOVANCE Anti-Xa assay. They are used for the quantitative determination of apixaban in citrated human plasma, and the set includes two levels: Control 1 (approximately 70 ng/mL) and Control 2 (approximately 260 ng/mL).
SMN/Catalog no.: 10873672/OPPV03
Package size: 2 × 5 × for 1 mL
9. INNOVANCE Anti-Xa Reagent
Image Credit: Siemens Healthineers
The INNOVANCE Anti-Xa reagent is an in vitro diagnostic tool designed for quantitative, WHO-standardized determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) activity. It is used to monitor patients undergoing UFH or LMWH therapy, analyzing human sodium citrated plasma via automated, chromogenic methods.
This assay features ready-to-use liquid reagents and utilizes a single hybrid calibration curve for LMWH and UFH. The INNOVANCE Anti-Xa reagent also serves as an in vitro diagnostic reagent for quantitatively determining direct factor Xa inhibitors such as rivaroxaban1, apixaban, and edoxaban1.
This helps assess the anticoagulant status of patients on these factor Xa inhibitor therapies, as well as automated, chromogenic methods using human sodium citrated plasma.
SMN/Catalog no.: 10873681/OPPU05
Package size: Kit
10. INNOVANCE Heparin LMW Control 2
Image Credit: Siemens Healthineers
INNOVANCE Heparin LMW Control 2 is used for quality control with the INNOVANCE Heparin and INNOVANCE Anti-Xa assays. This control helps ensure the accurate quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma, with a heparin concentration of approximately 1.0 IU/mL.
SMN/Catalog no.: 10873450/OPOE03
Package size: 5 × for 1 mL
11. INNOVANCE Heparin LMW Control 1
Image Credit: Siemens Healthineers
INNOVANCE Heparin LMW Control 1 is used for quality control of INNOVANCE Heparin and INNOVANCE Anti-Xa assays. It facilitates the quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) in citrated human plasma, with a heparin concentration of approximately 0.4 IU/mL.
SMN/Catalog no.: 10873449/OPOE03
Package size: 5 × for 1 mL
12. INNOVANCE Heparin Calibrator
Image Credit: Siemens Healthineers
These calibrators are used to calibrate the INNOVANCE Heparin and INNOVANCE Anti-Xa assays. Utilizing a hybrid calibration curve, they enable the quantitative determination of unfractionated heparin (UFH) and low-molecular-weight heparin (LMWH) activity in citrated human plasma. Notably, these calibrators are traceable to the WHO Standards for LMWH and UFH.
SMN/Catalog no.: 10873453/OPOB03
Package size: 5 × 1 ×for 1 mL
Clinical use
Why the lab should perform anti-Xa testing for anticoagulants
Labs are required to protect anticoagulant treatments like heparin or direct oral anticoagulants (DOACs) by testing patients for an increasing variety of drugs to monitor and control bleeding risks.
Why accurate DOAC assessment is imperative
Direct oral anticoagulants, such as rivaroxaban, apixaban, and edoxaban, are direct anti-Xa inhibitors that have evolved because of their ease of administration and short half-life.
Though the drug is typically not monitored, DOAC testing is required to adequately manage persons with bleeding diseases, in emergency scenarios requiring unanticipated surgery, and associated comorbidities (for example, renal insufficiency).
Why anti-Xa is the better choice for heparin testing
Heparin is a classic anticoagulant medication available in UFH and LMWH, which significantly accelerates the inactivation of coagulation factor Xa by antithrombin. Clinical evidence suggests that monitoring heparin using an anti-Xa assay has various advantages over APTT testing:
- Smoother dose-response curve
- Fewer dosage adjustments
- More stable heparin levels during therapy
- Fewer blood samples required
1. Not available for sale in the U.S. Product availability may vary from country to country and is subject to varying regulatory requirements.